B. Conduct ongoing monitoring of interventional trial by those who have appropriate expertise to accomplish the trial's mission: The MUSC clinical lab is required to notify the PI of any critical lab values. The Study Coordinators will be responsible for checking laboratories of the women within 72 hours of their reporting and then entering the laboratory data into the computer. They will be provided with a set of normative laboratory values as a reference. The Clinical PI will review values during the weekly study meeting or will be notified if a value falls outside of the referent value range. All data will be verified independently by the Data Processing Center under the direction of Dr. Hulsey. The DSMC will be notified via telephone and fax with source documents and adverse report sheets if a subject's value falls outside the referent value range. In addition, all adverse events will be reviewed quarterly by the DSMC, whose report will be forwarded to the Kellogg Foundation on a quarterly basis and the IRB yearly. The Investigators will report all Serious Adverse Events by telephone to the IRB and the DSMC; in addition, the IRB, the DSMC, and Kellogg Foundation will receive a written report within 10 days of the Clinical Investigators' knowledge of the Event. In addition, the investigators will generate a quarterly report to the DSMC regarding subject enrollment, subject completion, adverse events and serious adverse events. The DSMC will review the report and a summary letter with their findings sent to the IRB.